# K111519: Sterrad Sealsure Chemical Indicator Tape Model 14202

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Sterilization Products
- Decided: Oct 3, 2012 after 489 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022441 (2002). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103219: Sterrad Sealsure Chemical Indicator Tape, Advanced Sterilization Products (2011) Summary page 1.

## Most influential descendants
- K160485: VERIFY VH2O2 Indicator Tape (2016), 1 descendant of its own
- K234084: STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (2024), 0 descendants of its own
- K172753: VERIFY VH2O2 Indicator Tape (2018), 0 descendants of its own

## Indications for use
STERRAD® SEALSURE® Chemical Indicator Tape (PN 14202) is a process indicator (ISO 11140-1:2005) intended for use by healthcare providers to secure nbn-woven sterilization packs and wraps to be sterilized in the STERRAD®0 Sterilization Systems. MODEL CYCLE STERRAD® IQOOS Standard STERRAD7 50 S-t-andard STERRAD® 200 Standard STRA"NX® Standard STERRAD®Advanced Standard 10NX"Flex STERAD I0NX® STERRD® EXPRESS DUO The color of the STERRAD® SEALSIJRE® Chemical Indicator Tape changes from red to gold (or lighter) when exposed to hydrogen peroxide and is intended to differentiate between processed and unprocessed loads.

Source page: https://510kreport.com/device/K111519
Methodology: https://510kreport.com/methodology